FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
03/15/1995
Recalls and Field Corrections: Foods -- Class I -- 03/15/1995
March 15, 1995 95-11
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Various types of crabmeat in 1 pound plastic containers:
(a) Jumbo Lump; (b) Backfin; (c) Special.
Recall #F-489/491-5.
CODE None. Produced 12/8/94.
MANUFACTURER Casey's Seafood, Inc., Newport News, Virginia.
RECALLED BY Manufacturer, by telephone on or about December 23, 1994.
Firm-initiated recall complete.
DISTRIBUTION New York, Virginia, Pennsylvania.
QUANTITY 419 pounds was distributed, firm estimates none remains on
the market.
REASON Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS -- FOODS -- CLASS II
========================
_______________
PRODUCT Spumoni Ice Cream packaged in 3 gallon cardboard bulk
containers. Recall #F-496-5.
CODE All bulk product manufactured in 1994 and in 1995 until
January 27, 1995.
MANUFACTURER Hagan Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by delivering a "Products Information Notice"
on February 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Maryland, West Virginia, Ohio, Kentucky,
Virginia.
QUANTITY Undetermined.
REASON Product contains undeclared almonds.
_______________
PRODUCT Lime and Rainbow Sherbets packaged in 3 gallon cardboard
bulk containers. Recall #F-497/498-5.
CODE All bulk product manufactured in 1994 and 1995 until January
27, 1995.
MANUFACTURER Hagan Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by delivering a Products Information Notice"
on February 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Maryland, West Virginia, Ohio, Kentucky,
Virginia.
QUANTITY Undetermined.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Butter Pecan Ice Cream, packaged in 3 gallon cardboard bulk
containers. Recall #F-495-5.
CODE All bulk product manufactured in 1994 and in 1995 until
January 27, 1995.
MANUFACTURER Hagan Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by delivering "Product Information Notice" on
February 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Maryland, West Virginia, Ohio, Kentucky,
Virginia.
QUANTITY Undetermined.
REASON Product contains undeclared pecans.
_______________
PRODUCT Bottled drinking water in 1-gallon plastic jugs sold under
the Land O Sky and Morning Fresh labels. Recall #F-499-5.
CODE 25 APRIL 1995 H (second shift).
MANUFACTURER Sky King, Inc., Asheville, North Carolina.
RECALLED BY Manufacturer, by letter May 17, 1994. Firm-initiated recall
complete.
DISTRIBUTION North Carolina, South Carolina, Georgia, Tennessee,
Virginia, West Virginia.
QUANTITY 2,513 gallons (Land O Sky); 2,555 gallons (Morning Fresh)
were distributed.
REASON Product is contaminated with mold.
_______________
PRODUCT Peanut Butter Curl and Peanut Butter Cup Ice Cream packaged
in 3 gallon cardboard bulk containers. Recall #F-500/501-5.
CODE All bulk product manufactured in 1994 and in 1995 until
January 27, 1995.
MANUFACTURER Hagan Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by delivering a "Products Information Notice"
on February 1, 1995. Firm-initiated recall ongoing.
-2- DISTRIBUTION Pennsylvania, Maryland, West Virginia, Ohio, Kentucky,
Virginia.
QUANTITY Undetermined.
REASON Product contains undeclared peanuts.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Mezlin, sterile Mezlocillin Sodium, an antibiotic for the
treatment of serious infections caused by susceptible
strains of microorganisms: 1g, 2g, 3g, 4g, vials, and 3g,
and 4 g infusion bottles. Recall #D-079/084-5.
CODE Mezlin vials:
1g - 2DGN EXP 4/1/95; 4GEW EXP 7/1/97.
2g - 3LBF EXP 12/1/96; 4GAS EXP 7/1/97.
3g - 2EGL EXP 5/1/95; 2EGM EXP 5/1/95; 3GED, EXP 7/1/96,
3IHK EXP 9/1/96; 4BFB EXP 2/1/97; 4JIS, EXP 10/1/97.
4g - 2DGR exp 4/1/95; 2DGX EXP 4/1/95; 2EGN, EXP 5/1/95,
3GEZ EXP 7/1/96; 3IHM EXP 9/1/96; 3LEI, EXP 12/1/96,
4JIX EXP 10/1/97; 4BFD EXP 2/1/97.
Mezlin infusion bottles:
3g - 2CGD EXP 3/1/95; 2CGK EXP 3/1/95; 2FFL EXP 6/1/95;
3CGM EXP 3/1/96; 3HIM EXP 8/1/96; 4EBP EXP 5/1/97;
4HGB EXP 8/31/97.
4g - 3CGP EXP 3/1/96; 3HIP EXP 8/31/96; 4ECF EXP 5/1/97;
4GET EXP 7/1/97.
MANUFACTURER Bulk Sterile Drug, Bayer A.G., Germany.
RECALLED BY Miles, Inc., Pharmaceutical Division, West Haven,
Connecticut, by letter February 27, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10,000 units (10-packs) of vials or infusion bottles were
distributed.
REASON Error in dosage instructions in the package insert.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Source Plasma. Recall #B-192-5.
CODE Unit numbers: PH39303, PH39445, PH39706,
PH39860, PH40109, PH40379, PH40543, PH40793,
PH41384, PH41516, PH41770, PH42031, PH42214,
PH42457, PH42645, PH42908, PH43047, PH43464,
PH43663, PH43941, PH44107, PH44394, PH44582,
PH44825, PH45235, PH46037, PH46250, PH46462,
PH46793, PH46859, PH48002, PH48180, PH48427,
PH48648, PH49190, PH49604, PH51097, PH51331,
PH51595, PH51885, PH52090, PH52439, PH52881,
PH53220, PH53375, PH54794, PH55011, PH55328,
PH55523, PH55868, PH56351, PH56552, PH56874,
PH57085, PH57405, PH59752, PH60194, PH60586,
-3- PH60834, PH61170, PH61540, PH61841, PH62177,
PH62413, PH63208, PH63445, PH63971, PH64220,
PH65199, PH65708, PH66189, PH66610, PH66875,
PH67271, PH67514, PH67907, PH68286, PH78008,
PH78371, XH44468, XH45431, XH45797, XH59985,
XH64344, XH79926, XH81009, XH81317, XH81735,
XH81953, XH82558, XH82899, XH83292, XH84120,
XH84635, XH84995, XH85923, XH87525, XH87908,
XH88431, XH88771, XH89298, XH92067, XH92408,
XH92866, XH93193, XH93662, XH93921, XH93985,
XH94463, XH94793, XH95279, XH95644, XH96113,
XH96455, XH97258, XH97707, XH98062.
MANUFACTURER Community Bio-Resources, Inc., Atlanta, Georgia.
RECALLED BY Community Bio-Resources, Inc., Columbus, Georgia, by letter
June 14, 1994. Firm-initiated recall complete.
DISTRIBUTION Michigan, New Jersey, Austria.
QUANTITY 117 units.
REASON Blood products, which were collected from a donor who had a
history of intravenous (IV) drug use, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Vortran Medical Technology "VISAN-9" Intermittent Signal
Actuated Nebulizer, intended for delivering high
concentrations of respirable aerosols to patients on
ventilators. Recall #Z-426-5.
CODE Serial numbers 1000-251 through 1000-301 inclusive, except
for 1000-298.
MANUFACTURER Vortran Medical Technology, Sacramento, California.
RECALLED BY Manufacturer, by letter on or about January 2, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION North Carolina, Alabama, California, Florida, Michigan, New
York, Ohio, Oregon, Texas, Washington State, Canada
QUANTITY 49 units were distributed
REASON Gas leaks in the seams of the high pressure transducer
casings can trigger an alarm which then shuts off the gas
supply.
_______________
PRODUCT Thomoscan SR 600 Computed Tomography (CT) Systems,
diagnostic x-ray product. Recall #Z-458-5.
CODE None.
MANUFACTURER Philips Medical Systems, Shelton, Connecticut.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan March 2, 1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14 units.
-4- REASON The diagnostic x-ray devices were defective in accordance
with the Federal Performance Standard for Diagnostic X-Ray
Systems and Their Major Components. When the Scanogram mode
of operation is interrupted by premature release of the
start button and the patient table is moved within six
seconds, the generator may initiate x radiation
unintentionally.
_______________
PRODUCT Angiographic Needles, Biopsy Trays, and Biopsy Needles.
Recall #Z-461/470-5.
CODE (a) Biopsy Trays, Catalog Nos. 4000, 4100, 4125, various
lots;
(b) Enteroclysis Catheter, Catalog Nos. ET-412, ET-420,
various lots;
(c) Biopsy Needles Catalog Nos. MR1820, MR2020, MR2220,
N710, N715, N105, N115, N120, N205, N207, N210, N815, N820,
N905, NS19, NS21, NV115, NV120, NV815, NV910, NAH2204,
NAH2206, various lots; (All of the above distributed under
the E-Z-EM label)
(d) Entry Needles, Catalog Nos. 14500901, 14500902,
14501401, 14502001, 14502101, 06500801, 06500803, 06500901,
06505801, 54500901, 54500903, 70700803, various lots;
(e) Guidewires/Occluding Wires, Catalog Nos. 10200301,
12400101, 12400103, 12400701, 12400703, J35FC-150-053,
various lots;
(f) Angiographic Catheters, Catalog Nos. 10500101, 10500102,
10500103, 10500204, 10500402, 10500605, 10502401, 10502603,
10506002, 10506101, 10707101, 10707102, 10707201, 10707601,
10707701, 10707704, 10707706, 10707902, 10708101, 10708201,
10708202, 10708301, 10708501, 10708502, 10708504, 10708505,
10708602, 10708603, 10708604, 10709003, 10709110, 10709203,
10709503, 10709504, 10709505, 10709601, 10709602, 10709603,
10709706, 10709901, 10711001, 10711401, 10711402, 10718301,
10718505, 10719003, 10719103, 10719401, 10719501, 10719502,
10719604, 10719901, 10720201, 10720303, 10720305, 10720401,
10720402, 10720403, 10720404, 10720405, 10720406, 10720407,
10720408, 10720801, 10720904, 10721004, 10721101, 10721403,
10722401, 10723501, 10724401, 10724402, 10726901, 10729401,
12400204, 12400209, 12400404, 50500701, 50501101, 50501301,
50700601, 50701701, 50701901, 50702101, 50702301, 50702302,
50702501, 50703001, 50703002, 50703201, 50703401, 50703701,
50703901, 50707403, 50707406, 50708601, 50709602, 50716601,
50722617, 50722619, 52400401, 52500301, NZ4658P, NZ4908P,
NZ5656A, various lots;
(g) Pulse*Spray Pulsed Infusion Systems, Catalog Nos.
12500401, 12500403, 12500413, 12500417, 12500423;
(h) Pulse*Spray Accessory to Infusion System, Catalog No.
12400601, lot number B20161;
(i) Fluid Management Systems, Catalog Nos. 16000601,
16100301, 16100302, various lots;
-5- (j) High Pressure Connecting Lines, Catalog Nos. 10900201,
10900202, 10900203, 10900207, 10900208, 11900107, EZ12MF,
NZ36MF, NZ48RMF, various lots. (All of the above
distributed under Angio Dynamics (Div. of E-Z-EM) label).
MANUFACTURER Angio Dynamics, Division of E-Z-EM, Inc., Queensbury, New
York.
RECALLED BY E-Z-EM, Inc., Westbury, New York, by telephone December 6,
1994, followed by letter sent the week of December 20, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 96,736 E-Z-EM labeled units and 26,296 Angio Dynamics
labeled units were distributed.
REASON Sterility cannot be assured due to an inadequate heat seal
on the Tyvek & Mylar package pouch.
_______________
PRODUCT Pegasys 2.1 Software System used with imaging units.
Recall #Z-471-5.
CODE Software installed with each Pegasys System, Version 2.1.
MANUFACTURER ADAC Laboratories, Milpitas, California.
RECALLED BY Manufacturer, by performing upgrades to software (date)
beginning on or about October 7, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 616 software systems were distributed.
REASON An error in the software could cause a mix-up of patient
data, during transfer of patient's images which could lead
to misdiagnosis.
_______________
PRODUCT Synthes 4.0 mm Cervical Spine Plasma-Sprayed Fenestrated
Expansionhead Bone Screw, Product #487.14, used in
conjunction with the Synthes Anterior Cervical Vertebrae
Plate (Cervical Spine Locking Plate). Recall #Z-474-5.
CODE All lots.
MANUFACTURER Synthes (USA), Paoli, Pennsylvania.
RECALLED BY Manufacturer, by letter January 16, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Switzerland, Canada.
QUANTITY 35,251 units have been distributed.
REASON The subject cervical spine bone screw was marketed without
required premarket notification to FDA.
_______________
PRODUCT Imaging Tables used in nuclear medicine analysis conducted
in physicians' offices and laboratories:
(a) XYZ Imaging Table with Foot Pump;
(b) Scanning Cot; (c) EZ Lift Imaging Table with Foot Pump;
(d) Full-View Imaging Table. Recall #Z-484/487-5.
CODE Tables manufactured from May 90 through October 92.
MANUFACTURER Med Tron Products, Inc. Port Jefferson, New York.
-6- RECALLED BY Manufacturer, by letter October 22, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Canada.
QUANTITY 84 beds were distributed.
REASON The brake mechanism on the wheels did not work properly.
_______________
PRODUCT SoloPICC Peripheral Intravenous Central Catheters:
(a) Product 71920, SoloMidline Catheter, 20 gauge 8"
Catheter with 3FR Peelable Introducer;
(b) Product 71908, SoloMidline Catheter Insertion Kit, 20
gauge with 8" Catheter with 3 FR Peelable Introducer;
(c) Product 71956, SoloPICC Catheter, 20 gauge with 22"
Catheter with 3 FR Peelable Introducer;
(d) Product 71922, SoloPICC Catheter Insertion Kit, 20 gauge
with 22" Catheter with 3 FR Peelable Introducer.
Recall #Z-492/495-5.
CODE Lot numbers: (a) 407002, 407170, 410141;
(b) 409062, 410138, 411131
(c) 410144, 411135
(d) 407001, 407048, 407161, 409063, 410140, 411146, 412075
MANUFACTURER Medical Profiles, Inc., Lavonia, Michigan.
RECALLED BY SoloPak Medical Products, Inc., Elk Grove Village, Illinois,
by letter February 3, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, New York, California, Massachusetts, Illinois,
Florida, Tennessee, Michigan, Missouri, Maryland, Texas,
Indiana, Georgia, Ohio, Colorado, Connecticut.
QUANTITY 3,750 catheters were distributed; firm estimated that 40
percent of the product remained on market at time of recall
initiation.
REASON There is a potential for fluid leaks at the catheter/hub
connection.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT New Vues Softcolors Disposable Soft Contact Lenses, base
curve: 8.8, Diameter: 14.0, power: -1.50, color: royal
blue, packaging: 6 lens multipack. Recall #Z-472-5.
CODE Lot #3471280 EXP 10/99.
MANUFACTURER CIBA Vision Corporation, Duluth, Georgia.
RECALLED BY Manufacturer, by letter September 16, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Switzerland, Australia, Canada.
QUANTITY 238 multipacks were distributed.
REASON The product lot was manufactured and labeled as -1.50 sphere
power but may contain individual lenses of a -4.00 power,
which may result in inability to see out of the lens.
_______________
PRODUCT Infuse-a-Kit, an implantable drug delivery system.
Recall #Z-473-5.
-7- CODE Catalog No. Catheter French Lot No.
40051 10 230108-A
303403-A
303403-C
40057 8 219003-B
224107-B
230106-B
300604-A
40058 10 224104-B
220509-C
307702-B
40390 8 220404-B
41429 10 220503-D
223005-C
227304-D
304801-B
314505-A
MANUFACTURER Strato Medical Corporation, Beverly, Massachusetts.
RECALLED BY Strato/Infusaid, Inc., Pfizer Hospital Products Group,
Norwood, Massachusetts, by telephone August 23, 1994. Firm-
initiated recall complete.
DISTRIBUTION Alabama, California, Florida, Illinois, Massachusetts,
Maryland, Pennsylvania, South Dakota, Saudi Arabia.
QUANTITY 35 units were distributed.
REASON The kits contained the wrong size introducer set containing
either the 8 French or 10 French catheter.
_______________
PRODUCT Stratus-Digoxin Fluorometric Enzyme Immunoassay, an
automated procedure for the quantitative determination of
digoxin levels in serum and plasma samples.
Recall #Z-476-5.
CODE Catalog #B5700-10, lot numbers: XDK-2134, 2139, 2140, 2143-
2150, 2154-2168, 2170-2180, 2182-2258, XDK-14S, 15S, 16S.
MANUFACTURER Baxter Diagnostic of PR, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostics, Inc., Miami, Florida, by letter dated
December 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 16,229 kits were distributed.
REASON The device is subject to high control recovery.
_______________
PRODUCT 6+ Single-use disposable cartridge which is used in a
portable clinical analyzer. Recall #Z-488-5.
CODE Catalog #121000-01, lot #K93088 sublot A,B, and E, Cartridge
6+, EXP 5/5/94.
MANUFACTURER I-Stat, Canada Limited, Kanata, Ontario, Canada.
RECALLED BY I-Stat Corporation, Princeton, New Jersey, by telephone from
August 31, 1993 to September 1, 1993, and by letter August
31, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
-8- REASON The glucose test may give a low reading. This is due to the
glucose chip not being in the 6+ cartridge.
_______________
PRODUCT Abuscreen Ontrak for Benzodiazepine, an in-vitro diagnostic.
Recall #Z-489-5.
CODE The product # of the Benzodiazepine in-vitro diagnostic kit
is 42205 for the 50 test kit and 42221 for the 100 test kit.
There were two kits which the negative control lot #0005 was
a part of. The first one is a kit with 50 tests in it and
its' lot # is 20583 expiration date 1/27/94. The second one
is a kit with 100 tests in it and its' lot # is 22173
expiration date 1/27/94.
MANUFACTURER Roche Diagnostic Systems, Belleville, New Jersey.
RECALLED BY Manufacturer, by letter August 3, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON The negative control component of the subject device did not
meet the manufacturer's specification for agglutination
resulting in a positive result.
_______________
PRODUCT Abuscreen Online Automated Assays for Drug Abuse PCP, 100
test kit, an in-vitro diagnostic. Recall #Z-490-5.
CODE Product #43432, lot number of the kit containing the
contaminated microparticle is 43132 EXP 9/10/93.
MANUFACTURER Roche Diagnostic Systems, Belleville, New Jersey.
RECALLED BY Manufacturer, by letter March 15, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 157 kits were distributed; firm estimates none remains on
the market.
REASON False positive test results were obtained due to a reduced
curve span.
_______________
PRODUCT CEA-Roche-EIA Carcinoembryonic Antigen (CEA) Enzyme
Immunoassay Test Kit, an in-vitro diagnostic.
Recall #Z-491-5.
CODE Product #43348 for the 100 test kit, lot #48653 and the
product number for the 500 test kit is 43362, lot #61202.
Both kits contain control lot 0017 EXP 4/1/94.
MANUFACTURER Roche Diagnostic Systems, Belleville, New Jersey.
RECALLED BY Manufacturer, by letter March 22, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON The control lot in the product was bacterially contaminated.
-9- RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS: CLASS II
============
_______________
PRODUCT Agrimycin-100 Antibiotic, brand of Oxytetracycline
Hydrochloride Injection, 100 mg/ml, in 500 ml vials.
Recall #V-022-5.
CODE Lot numbers: H4L027, H4L028.
MANUFACTURER Anthony Products Company, Arcadia, California.
RECALLED BY Agri Laboratories, Ltd., St. Joseph, Missouri, by letter
February 2, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,785 vials of lot H4L027 and 3,788 vials of lot H4L028 were
distributed.
REASON Vials were cloudy and contained precipitate.
_______________
PRODUCT Oxytetracycline Hydrochloride Injection Antibiotic, in 500-
ml vials, under Pacific Animal Health and VEDCO labels.
Recall #V-023-5.
CODE Lot #H4K008 EXP 10/96.
MANUFACTURER Anthony Products Company, Arcadia, California.
RECALLED BY Manufacturer, by telephone between December 14 and 16, 1994.
Firm-initiated recall complete.
DISTRIBUTION Arizona, California, Florida, Iowa, Illinois, Missouri,
Nebraska, New York, Pennsylvania, Texas, Puerto Rico.
QUANTITY 3,778 vials were distributed.
REASON Product not processed in accordance with good manufacturing
practices.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT TM-50 Type A Medicated Article containing Terramycin
(Oxytetracycline) packaged in 50 pound bags, labeled for
disease prevention and treatment, and weight gain and feed
efficiency in numerous domestic animal species.
Recall #V-020-5.
CODE NH1005-1.
MANUFACTURER International Manufacturing & Sales, Inc., Omaha, Nebraska.
RECALLED BY Manufacturer, by letter June 27, 1994. Firm-initiated
recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 81 bags were distributed.
REASON Product was subpotent (84.3/89.6% of declared value).
_______________
PRODUCT Bovatec Cattle Supplement M, Type B Medicated Article
containing lasalocid - in 50 pound bags labeled for improved
feed efficiency and increased rate of weight gain in
confinement feed beef cattle. Recall #V-021-5.
CODE NB0603-3.
MANUFACTURER International Manufacturing & Sales, Inc., Omaha, Nebraska.
RECALLED BY Manufacturer, by telephone February 12, 1993. Firm-
initiated recall complete.
-10- DISTRIBUTION Iowa.
QUANTITY 41 bags were distributed.
REASON Product was subpotent.
_______________
PRODUCT BMD-50 Type A Medicated Article containing bacitracin
methylene disalicylate packaged in 5 pound bags, labeled for
increased rate of weight gain and improved feed efficiency
and for control of swine dysentery. Recall #V-024-5.
CODE OC0201-2.
MANUFACTURER International Manufacturing and Sales, Inc., Omaha,
Nebraska.
RECALLED BY Manufacturer, by letters of June 13 and 27, 1994. Firm-
initiated recall complete.
DISTRIBUTION Iowa, Nebraska.
QUANTITY 19 bales containing 10 bags each were distributed.
REASON Product was subpotent (38.4% to 54.4% of declared value).
-11-
END OF ENFORCEMENT REPORT FOR MARCH 15, 1995. BLANK PAGES MAY
FOLLOW.
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